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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03061370
Other study ID # SJHDOS2016-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date January 1, 2019

Study information

Verified date March 2020
Source St. James's Hospital, Ireland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In line with improvements in oncologic outcome for patients with esophageal cancer, the attritional impact of curative treatment with respect to functional status and health-related quality of life (HR-QL) in survivorship is increasingly an important focus. Functional recovery after surgery for esophageal cancer is commonly confounded by anorexia and early satiety, which may reduce oral nutrient intake with consequent malnutrition and weight loss. One in three disease-free patients has more than fifteen percent body weight loss at three years after esophagectomy.

The ESPEN Special Interest Group on cachexia-anorexia in chronic wasting diseases has defined sarcopenia as skeletal muscle index (SMI) of ≤39 cm2/m2 for women and ≤55cm2/m2 for men, while similar cut-off points have been validated in upper gastrointestinal and respiratory malignancies (less than 38.5 cm2/m2 for women and 52.4 cm2/m2 for men). The European Working Group on Sarcopenia in Older People (EWGSOP) additionally recommends that assessment should also include determination of muscle function, for example gait speed or grip strength, where possible.

The presence of sarcopenia is associated with increase treatment-associated morbidity, impaired HR-QL, reduced physical and role functioning, and increased pain scores in older adults. In addition, a previous longitudinal study demonstrated that the decline in HR-QL over a six year period in older adults was accelerated in the presence of sarcopenia. As such, sarcopenia may represent a modifiable barrier to recovery and subsequent retention of HR-QL and functional status, and may reinforce a persistent illness identity, among patients following potentially curative treatment for esophageal cancer.


Recruitment information / eligibility

Status Completed
Enrollment 317
Est. completion date January 1, 2019
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Initial staging computed tomography (CT) scan capturing the level of the L3 conducted at our Centre and available for review

Exclusion Criteria:

- Patients who had a history of previous gastrointestinal resection, other active malignancy, eating disorder, inflammatory bowel disease or other significant illness that might alter body composition were excluded from analysis.

Study Design


Intervention

Procedure:
Esophagectomy or Gastrectomy
Surgical resection

Locations

Country Name City State
Ireland Department of Surgery, St. James's Hospital Dublin
Ireland Wellcome Trust-Health Research Board Clinical Research Facility, St. James's Hospital Dublin

Sponsors (1)

Lead Sponsor Collaborator
St. James's Hospital, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (3)

Doyle SL, Bennett AM, Donohoe CL, Mongan AM, Howard JM, Lithander FE, Pidgeon GP, Reynolds JV, Lysaght J. Establishing computed tomography-defined visceral fat area thresholds for use in obesity-related cancer research. Nutr Res. 2013 Mar;33(3):171-9. doi: 10.1016/j.nutres.2012.12.007. Epub 2013 Jan 30. — View Citation

Elliott JA, Doyle SL, Murphy CF, King S, Guinan EM, Beddy P, Ravi N, Reynolds JV. Sarcopenia: Prevalence, and Impact on Operative and Oncologic Outcomes in the Multimodal Management of Locally Advanced Esophageal Cancer. Ann Surg. 2017 Nov;266(5):822-830. — View Citation

Prado CM, Lieffers JR, McCargar LJ, Reiman T, Sawyer MB, Martin L, Baracos VE. Prevalence and clinical implications of sarcopenic obesity in patients with solid tumours of the respiratory and gastrointestinal tracts: a population-based study. Lancet Oncol. 2008 Jul;9(7):629-35. doi: 10.1016/S1470-2045(08)70153-0. Epub 2008 Jun 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Neoadjuvant therapy toxicity 6 months
Primary Postoperative morbidity 6 months
Primary Oncologic outcome 6 months
Primary Survival 5 years
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